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Selective Estrogen Receptor Modulator

Tamoxifen for Breast Cancer Risk Reduction

Phase 2
Waitlist Available
Led By Seema A Khan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women with HSV infection on suppressive antiviral therapy
Participants aged 18 to 55
Must not have
History of SERM use within the past 5 years with duration of use > 1 year
History of invasive breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6, 12, and 18 months
Awards & highlights

Summary

This trial is testing a low dose of tamoxifen to see if it can reduce breast density in women who have a higher risk of breast cancer. Breast density is a known risk factor for breast cancer

Who is the study for?
This trial is for premenopausal women at higher than average risk for breast cancer, particularly those with dense breasts. The study aims to find the best dose of Tamoxifen that can reduce breast density and thus lower the risk of developing breast cancer.
What is being tested?
The RENAISSANCE Trial is testing low-dose Tamoxifen's effectiveness in reducing breast density among high-risk women. It includes assessments like questionnaires, biopsies, biospecimen collection, and mammography to monitor changes and responses.
What are the potential side effects?
Tamoxifen may cause side effects such as hot flashes, vaginal dryness or discharge, menstrual irregularities, fatigue, mood swings, and a slight increase in the risk of blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman taking medication to control my HSV infection.
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I am between 18 and 55 years old.
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I can take care of myself but might not be able to do active work.
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I am a premenopausal woman according to age and hormone levels.
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I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.
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I am a woman with controlled hepatitis B.
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I use hormonal contraceptives and will not change them during the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have used SERMs for more than a year in the last 5 years.
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I have had invasive breast cancer before.
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I have a history of uterine cancer or abnormal cell growth in my uterus, and my uterus has not been removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6, 12, and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6, 12, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of women who have a response at any time point
Secondary outcome measures
Adherence to final tamoxifen dose
Baseline dense area
Longitudinal change in serum biomarkers of tamoxifen response
+2 more
Other outcome measures
Breast tissue-based biomarkers
Change in breast cancer risk estimates
Single nucleotide polymorphisms (SNPs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (tamoxifen)Experimental Treatment5 Interventions
Participants receive tamoxifen 5mg PO QD for 6 months. Participants with aDAR >= 10% on mammogram at 6 months continue receiving tamoxifen 5mg PO QD for 12 months. Participants with aDAR < 10% at 6 months are escalated to receive tamoxifen 10mg PO QD for 6 months. Participants with aDAR >= 10% after 6 months of tamoxifen 10mg continue receiving tamoxifen 10 mg PO QD for 6 months. Participants with aDAR < 10% after 6 months of tamoxifen 10mg are given the option of continuing tamoxifen 10mg or escalating to receive tamoxifen 20mg PO QD for 6 months. Participants undergo mammography and collection of blood samples at screening and on study. Participants may optionally undergo biopsy at screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Tamoxifen
2005
Completed Phase 4
~30070
Biopsy
2014
Completed Phase 4
~1090
Mammography
2015
N/A
~1450

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,201 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
Seema A KhanPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
102 Total Patients Enrolled
Lisa BarroilhetPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
104 Total Patients Enrolled
~133 spots leftby Dec 2027
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